Randomized Phase IIb Preprostatectomy Study of Dietary Supplementation With Soy and Biomarkers of Prostate Cancer Risk and Progression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Correlation of pretreatment ER-β expression with response to soy supplementation
研究概览
简要总结
RATIONALE: Dietary supplementation with soy may keep prostate cancer from growing in patients planning to undergo surgery.
PURPOSE: This randomized phase II trial is studying a soy supplement to see how well it works compared to a placebo in treating patients undergoing surgery for localized prostate cancer.
详细描述
OBJECTIVES:
Primary
- Compare the effect of dietary supplementation with soy vs placebo on biomarkers of cell cycle regulation, proliferation, differentiation, apoptosis, and signaling pathways in patients with localized prostate cancer scheduled to undergo radical prostatectomy.
Secondary
- Compare the toxicity and side effects of these regimens in these patients.
- Compare the dietary patterns of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinically localized disease
- •Scheduled for radical prostatectomy
- •No evidence of metastatic disease by bone scan or CT scan of the abdomen or pelvis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •No evidence of active nephrolithiasis
- •No history of hypercalcemic syndrome
- •PRIOR CONCURRENT THERAPY:
- •No prior treatment for prostate cancer, including radiotherapy, systemic chemotherapy, surgery, or investigational drugs
- •No other concurrent dietary supplementation with soy, cholecalciferol (vitamin D), or fish oil
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
干预措施: soy isoflavones (Dietary Supplement)
Arm I
Patients receive oral soy supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of soy supplementation.
干预措施: soy protein isolate (Dietary Supplement)
Arm II
Patients receive oral placebo supplementation daily for 4 weeks. Patients undergo radical prostatectomy within 21 days after completion of placebo supplementation.
干预措施: placebo (Other)
结局指标
主要结局
Correlation of pretreatment ER-β expression with response to soy supplementation
时间窗: within 21 days after completetion of supplement regimen
after a 4 week therapy, within 21 days, a Radical Prostatectomy will be performed, and after that ER-β expression will be measured.
次要结局
未报告次要终点